Evaluating Smoking Cessation Interventions for PWH in South Africa

Официальное название

Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness

Обзор

The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.

Подробное описание

This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) peer support, (3) combination nicotine replacement therapy (c-NRT), and (4) varenicline. The investigators will also evaluate the implementation and cost-effectiveness of these interventions. This study is a balanced full factorial randomised trial of 660 adults with HIV and will be implemented in two diverse sites in Gauteng, South Africa representing both peri-urban and urban settings.

Participants will be recruited via health care worker-referral or self-referral. Interested patients will be further screened for eligibility. Eligible participants will be administered written informed consent (see "Informed Consent and Assent" section below), and participants will be randomized into one of 16 study conditions for a 12-week intervention period. This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.

Вмешательства

• Препарат Varenicline
  At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.
• Препарат Nicotine patch
  A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package.
• Препарат Nicotine gum
  A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package.
• Поведенческое Intensive Behavioral Counselling
  Participants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (\~45 minutes) behavioural counselling in the clinic at screening and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice.
• Поведенческое Peer Counselling
  Participants randomized to the Peer Support condition will be engaged by a peer counsellor over weeks -2 to 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during weeks -2, 2, 4, 8 and 12;

Первичные конечные точки

• 7-day point prevalence tobacco abstinence at 52 weeks [Срок оценки: 52 weeks]

Вторичные конечные точки (2)

• 7-day point prevalence tobacco abstinence at 26 weeks [Срок оценки: 26 weeks]
• 7-day point prevalence tobacco abstinence at 12 weeks [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• ≥18 years of age, and
• attend one of the selected study clinics, and
• have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and
• have been taking ART for at least three consecutive months or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and
• are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and
• either own or have household access to a mobile phone, and
• provide written informed consent.

Критерии исключения

• Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
• are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
• have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
• have generalized eczema or psoriasis, or
• have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or
• have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or
• are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or
• have a history of adverse reactions to varenicline or nicotine patch, or
• are not planning to continue to receive care at the clinic for the next 52 weeks, or
• are a household member of a currently enrolled participant in this trial, or
• In the opinion of the attending investigator are not a candidate for the clinical trail.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• Perinatal HIV Research Unit (PHRU) — Soweto

Публикации

• Genade LP, Steiner L, Nabeemeeah F, Niaura RS, Nonyane BAS, Hoffmann CJ, Sohn H, Kemp CG, Guastaferro K, Mlambo L, Chetty D, Waja Z, Martinson N, Golub JE, Elf JL. Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework: The Tlogela Trial protocol. Contemp Clin Trials. PMID 40543725

Идентификаторы

NCT: NCT05413122 · IRB00335707 · 1U01CA261626-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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